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Last Updated: November 4, 2024

Miconazole - Generic Drug Details


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What are the generic sources for miconazole and what is the scope of patent protection?

Miconazole is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Galt Pharms, Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Taro, P And L, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.

Summary for miconazole
Drug Prices for miconazole

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Drug Sales Revenue Trends for miconazole

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Recent Clinical Trials for miconazole

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ain Shams UniversityPhase 3
Hill Dermaceuticals, Inc.Phase 3
Cairo UniversityPhase 3

See all miconazole clinical trials

Pharmacology for miconazole
Drug ClassAzole Antifungal

US Patents and Regulatory Information for miconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medtech Products MONISTAT 7 miconazole nitrate CREAM;VAGINAL 017450-002 Feb 15, 1991 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-003 Jun 17, 2003 OTC Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 3 COMBINATION PACK (PREFILLED) miconazole nitrate CREAM;TOPICAL, VAGINAL 021261-001 Feb 2, 2001 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette MICONAZOLE 7 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 076585-001 Mar 26, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074366-001 Feb 22, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva MICONAZOLE NITRATE miconazole nitrate CREAM;VAGINAL 074136-001 Jan 4, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for miconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Sign Up ⤷  Sign Up
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Sign Up ⤷  Sign Up
Galt Pharms ORAVIG miconazole TABLET;BUCCAL 022404-001 Apr 16, 2010 ⤷  Sign Up ⤷  Sign Up
Janssen Pharma MONISTAT miconazole INJECTABLE;INJECTION 018040-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.